This report is being submitted as a cancellation report.Based on review of additional information provided and the completed investigation this complaint no longer meets the fda mdr reporting criteria of a malfunction or serious injury report.Investigation details: complaint device was not returned therefore a document based review will be performed.It had been indicated that 1 x echo-hd-22-ebus-o of lot number c1593827 was going to be returned but to date this has not occurred.Clarification was requested to determine if it was the needle or stylet which the user had difficulty with and this was confirmed to be the stylet.Prior to distribution, all echo-hd-22-ebus-o devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for echo-hd-22-ebus-o of lot number c1593827 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1593827.The notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause for the customer complaint could not be determined from the available information.Due to limited information and non-return of the device a possible root cause could be attributed to general handling.Complaint is confirmed based on the customer's testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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